Manager - CAPA Effectiveness
Core
Strategic leadership for the site's CAPA Effectiveness Program, ensuring corrective and preventive actions effectively address root causes and prevent recurrence in pharmaceutical manufacturing.
Role type
Manager, Quality Assurance (CAPA Effectiveness)
Builds
Quality Management System (QMS) compliance and continuous improvement in Drug Product Division manufacturing
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
CAPA program leadership, root cause analysis (5 Whys, Fishbone, Fault Tree, Kepner-Tregoe), regulatory compliance (FDA 21 CFR, EU GMP, ICH Q9/Q10), data analytics for quality metrics, cross-functional collaboration, risk-based methodology design
Preferred skills
FDA and international regulatory inspection support, eQMS platforms (TrackWise, Veeva Quality, MasterControl)
Technologies
TrackWise, Veeva Quality, MasterControl
Responsibilities
Lead and improve the site's CAPA Effectiveness Program for deviations and quality events; Establish standardized, risk-based methodologies for CAPA development, implementation, and closure; Partner with investigators to ensure CAPAs address true root causes; Develop risk-based effectiveness verification strategies using quantitative and qualitative measures; Ensure CAPA processes comply with global regulatory requirements; Develop and report quality metrics including CAPA effectiveness rate and repeat deviation rates
Seniority
Manager, 3+ years leadership experience